The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Integra Camino Intracranial Pressure (ICP) Monitor (Catalogue Number: CAM02; serial number: all) and the Integra Licox PtO2 and Temperature Monitor (Catalogue Number LCX02; serial number: all ) manufactured by Integra Lifesciences (Ireland) Ltd.
According to the alert, the speakers in Camino ICP Monitors (CAM02) and the Licox PtO2 and Temperature Monitors (LCX02) may potentially malfunction. If this occurs, the monitors will stop providing an audible tone at start-up or at alarm points during use. Although unlikely, this may lead to central herniation that could potentially result in brain death or reversible ischemia; moderate hypoxic brain injury; elevation of ICP or decrease in PtO2. No reports of patient injury or adverse events have been received.
The affected units are to be returned to the manufacturer for a software upgrade to lower the input signal supplied to the speaker assembly. The monitor case will also be modified to increase the decibel level.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-00030-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 January 2016